Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — Investor Presentation (January 2017)
25 slides from Scorpius's investor presentation, Jan 6, 2017
Slide 1: Heat Biologics
Heat Biologics NASDAQ:HTBX
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes statements that are, or may be deemed, ‘‘forward-looking statements.’’ In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expec
Slide 3: Investment Opportunity
Investment Opportunity 3 Platform technologies designed to activate and expand “killer” T cells against multiple tumor antigens Focused on immuno-oncology (I-O) combinations that have the potential to dramatically improve patient outcomes Conducting vaccine + PD-1 checkpoint inhibitor combo trial in
Slide 4: Unmet Need in Immuno-Oncology (I-O)
Unmet Need in Immuno-Oncology (I-O) Clinical responses to checkpoint therapy (e.g., Opdivo®) occur primarily in patients who are:PD-L1 positiveTumor infiltrating lymphocyte (TIL) positive 4 Survival Time 15-30% response rates (NSCLC, bladder cancer, etc.) Market addressable with combination I-O Curr
Slide 5: Majority of Patients do not Respond to Checkpoints
Majority of Patients do not Respond to Checkpoints 5 Heat is focusing on converting ‘cold’ tumors to ‘hot’ tumors by activating highly specific “killer” T cells Source: Teng et al., 2015 Can Res Heat’s focus is on the majority of patients who do not respond to checkpoint therapy (low TIL) Only ~25%
Slide 6: Vision and Strategy
Vision and Strategy Focused on I-O combinations that have the potential to dramatically improve patient outcomes 6 Activation of CD8+ “killer” T cells Co-stimulation to enhance immune response Overcome tumor defenses through combination therapies
Slide 7: Heat's Product Development
Heat’s Product Development 7 Cancer Cell Lines & Patient Samples Heat’s AntigenScreening & Selection Algorithm Transition to CMOto Mass Produce Select Cell Line with Most Antigen Overlap Transfect with Heat’s Technology Platform Technology Highlights Applies to multiple cancers and infectious diseas
Slide 8: ImPACT Platform Technology
ImPACT Platform Technology 8 Intradermal injectedImPACT cells ImPACT cells secrete Gp96-Ig chaperone + tumor antigens (TAA) ImPACT Cells Gp96-Ig+TAA Selectively activate CD8+ T Cells CD8+ T-Cells Dendritic Cells CD8+ T cells circulate & eliminate tumor cells Tumor Cells CD8+ CD8+ CD8+ CD8+ 2 Dual an
Slide 9: Clinical Proof of Concept
Clinical Proof of Concept 9 Secrete Gp96-lg Pan-Antigen T Cell Activation Tumor Infiltration Future I-O combinations will focus on checkpoint blockade and durable T cell responses
Slide 10: Antigen Overlap with Patient Tumors
Antigen Overlap with Patient Tumors 10 Product candidate was selected due to high expression of >30 shared cancer antigens >15 of these antigens were also found in individual patient tumors Source: Heat’s HS-410 Ph 1b NMIBC trial results This information can be used to track whether the proliferatin
Slide 11: Polyclonal T Cell Activation
Polyclonal T Cell Activation 11 ImPACT Cells Gp96-Ig+TAA Gp96-Ig+TAA Dendritic Cells Gp96-Ig+TAA Dendritic Cells T Cell Proliferation Low numbers of proliferating T cells pre-vaccine Higher numbers of proliferating T cells post-vaccine T Cell Receptor Sequencing from Patient Blood Revealed: Source:
Slide 12: Pan-Antigen "Killer" T Cell Activation
Pan-Antigen “Killer” T Cell Activation 12 Antigen-specific immune responses were measured against individual antigens (e.g., survivin and NY-ESO-1) Antigens included in initial analysis Source: Heat’s HS-110 Ph 1b NSCLC trial results reported at World Lung Conf in Dec. 2016; HS-410 Ph 2 NMIBC trial
Slide 13: Increasing TILs at the Tumor Site
Increasing TILs at the Tumor Site Images of the bladder (above) showed changes that resemble lymphoid (T cell rich) structures, which we believe indicates that HS-410 leads to a localized immune response within the bladder Blue-light cystoscopy from patient treated with HS-410 Tumor biopsy from pati
Slide 14: ImPACTing the Tumor Microenvironment
ImPACTing the Tumor Microenvironment 14 PD-L1 Staining CD8 Staining Increased PD-L1 after 10 weeks of HS-110 + nivolumab Conversion from Low TIL to High TIL after 10 weeks of HS-110 + nivolumab Baseline Week 10 Source: Data extracted from two patients as reported in Heat’s HS-110 Ph 1b NSCLC trial r
Slide 15: Favorable Safety Profile To-Date
Favorable Safety Profile To-Date Over 1,000 doses administered in ~200 patientsFavorable safety profile and well-toleratedNo additive toxicities or serious adverse reactions No systemic use of steroids was required 15 Injection Reactions Week 1 Week 2 Immune Reactions*(≤ Grade 3 toxicity) *Represent
Slide 16: Fulfill Unmet Need for Non-Small Cell Lung Cancer
Fulfill Unmet Need for Non-Small Cell Lung Cancer 16 1. National Cancer Institute 2013 statistics; Graphic source: Teng et al., 2015 Can Res; Gettinger et al., 2015 JCO CD8+ (TIL+) patients may respond to anti-PD-(L)1 CD8- (TIL-) patients may not respond to anti-PD-(L)1 Approx. 50% PD-1 ORR Approx.
Slide 17: HS-110 NSCLC Trial Overview
HS-110 NSCLC Trial Overview HS-110 weekly intradermally for 18 weeks; nivolumab i.v. every other week until progression Objective Evaluate safety and tolerability of HS-110 + a PD-1 checkpoint inhibitor Patient Population Potential to expand each cohort up to 30 patients1 Secondary Endpoints Immune
Slide 18: Immune Response Correlates with Overall Survival
Immune ResponseCorrelates with Overall Survival 18 Source: HS-110 Ph 1b NSCLC data (left); HS-110 Ph 1b NSCLC data reported at World Lung Dec. 2016 (right)
Slide 19: ComPACT Platform Technology
ComPACT Platform Technology 19 gp96-Ig OX40L-Fc The first potential dual-acting immunotherapy designed to deliver T cell activation and costimulation in a single product – combination therapy without additive costs
Slide 20: ComPACT Outperforms OX40 Monoclonal Antibodies in Preclinical Models
ComPACT Outperforms OX40 Monoclonal Antibodies in Preclinical Models 20 ComPACT alone leads to ~50% complete tumor rejection as compared to ~16% with OX40 agonist antibody combinations1 Source: 1) Demonstrated in preclinical models for CT26 – Colon Cancer; Fromm et al. Society for Immunotherapy of C
Slide 21: ComPACT Synergizes with PD-1 Blockade
ComPACT Synergizes with PD-1 Blockade 21 % of CD8+ T Cells(CD127+KLRG1+) Frequency of Memory CD8+ Cells Source: Fromm et al. Society for Immunotherapy of Cancer Annual Meeting, 2016 ComPACT synergizes with PD-1 blockade to drive memory “killer” T cell differentiation
Slide 22: Leveraging gp96 Platform to Target Zika Virus & Other Infectious Diseases
Leveraging gp96 Platform to Target Zika Virus & Other Infectious Diseases Zolovax, a wholly-owned subsidiary, formed to leverage our platform into infectious diseasesCollaborating with the University of Miami (UM) to explore whether the gp96 vaccine might stimulate a similar virus-specific response
Slide 23: Highlights
Highlights Clinical proof of conceptFavorable safety profile and low toxicities to-datePan-antigen “killer” T cell activation and expansionApplicable to multiple cancers and infectious diseasesReady-to-use; scalable, low cost manufacturingUnencumbered commercialization rights 23 Focused on I-O combi
Slide 24: Financial Snapshot
Financial Snapshot 24 1. As of January 4, 2017; 2. As reported for the three months ended September 30, 2016 Nasdaq HTBX Shares Outstanding 23.9M Share Price $0.901 Market Cap $21.5M1 Cash & Equiv. $8.5M2 Founded in 2008, completed IPO 2013
Slide 25: Thank You
eat Biologics THANK YOU
Heat Biologics — Investor Presentation (January 2017) on 6ix